Mineralocorticoid Receptor in the Treatment of Severe Depression

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Major Depression

Treatments: Drug: fludrocortisone; Drug: Spironolactone; Drug: escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT00295347

OT 209/3-1

Details and patient eligibility

About

The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Depressed male and female inpatients according to DSM-IV
• Age between 18 and 70 years
• Minimum of 17-items Hamilton Depression Score of 18
• Informed consent signed

Exclusion criteria

• Relevant medical or neurological disorders
• Pregnancy or unsure contraception
• Relevant psychiatric comorbidity
• Active alcohol or other substance abuse/dependance
• Contraindications to SSRI, fludrocortisone, or spironolactone
• Steroid medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind